Dental handpiece performance sensor

ABSTRACT

Operation of a handpiece is sensed, such as by detecting temperature and/or vibration associated with one or more of the bearing rings supporting the turbine in the handpiece. When operation exceeds a threshold, a visual or audible indication is provided, and power to the turbine may be interrupted. The sensor(s) may be built into the handpiece, or be part of a removable girdle placed on the handpiece. Typically, the handpiece is used for dental or medical applications.

BACKGROUND OF THE INVENTION

The present invention relates to managing product information, and moreparticularly, is directed to creating product information, including, insome cases, product tag information, to reflect the product's historyand destination, and then updating the information to reflect productusage and exception events.

For medical products, such as pharmaceuticals and devices, somegovernment regulations define information about the product as beingpart of the product. Regulations from different governments mayconflict.

Certain government regulations further define the “label” for a medicalproduct as comprising certain information affixed to the product'scontainer as well as certain information accompanying the product, suchas a written sheet with usage instructions or other information.

Government regulations for medical products differ by country, and mayinclude requirements such as:

-   -   making information available in Braille or audio for blind or        partially-sighted customers,    -   recording and reporting, within a first time period, of fatal or        life-threatening experiences with the medical product,    -   recording and reporting, within a second time period, of        serious, unexpected, adverse experiences with the medical        product,    -   recording and reporting, within a third time period, of all        adverse experiences with the medical product,    -   storing, for a fourth time period, of all correspondence        relating to experiences with the medical product, and    -   ability to track a medical product through its life-cycle,        defined as all or part of manufacturing, distribution and usage.

Further, a single medical product may be subject to different regulatoryor procedural regimes, depending on how the product is used, e.g., givenby a physician, or used by a consumer at home.

Best practices suggest that recording negative quality experiences,adverse reactions and other information associated with lot numbers orserial numbers helps focus quality initiatives.

In regions such as Europe, a medical products distributor may have tocomply with preparing product labels in approximately 20 differentlanguages.

A product distributor is a party other than the manufacturer, end user,or end user's medical services provider. Thus, a pharmacy can serve as adistributor.

Internet Publicationhttp://www.devicelink.com/pmpn/archive/98/09/005.html discloses amedical packaging system for a medical products manufacturer, whichutilizes a multilingual labeling sub-system in order to comply withEuropean multiple-language labeling requirements. The sub-system scans aroute sheet for a specific product code, and then compiles variabletext, including language(s) for labels. A medical products manufactureruses a language database, programs its printers to pull information fromthe database, and prints on packages produced from form-fill-sealmachines.

It will be appreciated that the needs and capabilities of a manufacturerare different than those of a distributor.

For branded products from certain manufacturers that are distributed bymultiple distributors, being able to prove that problem products weredistributed by other than a specified distributor is of interest.Specifically, in products liability lawsuits where it is substantiallyimpossible to prove which distributor distributed the problem products,it may be the case that liability is assigned to all distributorstypically in proportion to their market share. Thus, the distributorswith the largest market share have an interest in proving that theproblem products came from distributors other than themselves.

U.S. Publication No. 20030229543 to Shannon M. Zimmerman et al. relatesto centralized management of packaging data with rule-based contentvalidation, which provides an online environment whereby manufacturersmanage packaging data for their products. FIG. 14 illustratestranslations data entry window 108E of user interface 101 that allowsthe user to select one or more languages 136 for translation andprinting on a label of the packaging data. In this manner, any textprinted on the label may be multilingual.

Another concern for medical products is that the device be properlyprogrammed and used. For example, infusion pumps should be programmed todispense the correct dose. At present, each device has its own userinterface and terminology including dosing units. Further, nursescalibrate devices in different ways: manually, via monitors, or via thedevice itself. Some hospitals develop rule libraries of drug dosingunits and dosage limits, and they load the rule libraries into thedevices, along with actions required and/or suggested if something isout of range. It has been proposed to add monitoring and interruptioncapability to patient-controlled infusion devices.

Some medical devices are too small to have barcode labels affixed to thedevice. Affixing such labels particularly increases labeling, storageand transportation costs. Some small manufacturers are unwilling toinvest in labeling systems to comply with lot and expiration barcoderequirements, or affixing radio frequency identification (RFID) tags.

It is known to print information such as a bar code with electricallyconductive ink. As used herein and in the claims, bar code refers to aconventional bar code, a data matrix, and techniques for representingprinted information in condensed form relative to alphanumeric text.

Mobile communications have been proposed in the health area. SIMpill, aSouth African firm, makes a small device that clips on to a medicationbottle and sends a text message to a central computer when the cap isremoved. If no message arrives, the central computer sends a textmessage reminder to the patient's mobile phone.

As another example, LG, a South Korean handset manufacturer, sells aphone with a built-in blood glucose meter, for use by diabetics, thattransmits readings to a computer for further analysis.

An example, from the automotive field, of transmitting sensor readingsin conjunction with location is the General Motors OnStar system. Withinseconds of a moderate to severe vehicle crash, the vehicle's OnStarmodule will send a message to the OnStar Call Center (OCC) through acellular connection, informing an advisor at the call center that acrash has occurred. A voice connection between the advisor and thevehicle occupants is established. The advisor then can conference in 911dispatch or a public safety answering point (PSAP), which determines ifemergency services are necessary. If there is no response from theoccupants, the advisor can provide the emergency dispatcher with thecrash information from the vehicle's sensing and diagnostic module thatreveals the severity of the crash. The dispatcher can identify whatemergency services may be appropriate. Using the Global PositioningSystem (GPS) satellites, OnStar advisors are able to tell emergencyworkers the location of the vehicle.

It is expected that government regulations, the needs of customers formore information, as well as the desire to provide more features tocustomers, will result in increasing demands relating to the scope andavailability of product information. For example, when customers cantrack their goods through the distribution process, the customers cantreat distributor facilities as the customers' inventory warehouses.

Accordingly, there is room for an improved product information system.

SUMMARY OF THE INVENTION

In accordance with an aspect of this invention, there is provided aremovable girdle for a handpiece, the handpiece having a head with aturbine supported by at least one bearing ring, comprising an elementfor detecting an operating condition of the at least one bearing ring,and at least one sensor for sensing whether the detected operatingcondition exceeds a threshold, and for providing an indication when thethreshold is exceeded.

In some cases, the element consists of a first band configured tocorrespond with a back bearing ring of the handpiece, and a second bandconfigured to correspond with a front bearing ring of the handpiece. Theoperating condition is represented by the temperature and/or thevibration of the handpiece head. A flexible membrane covers the back ofthe handpiece head, or a stabilizer clip for supports the girdle againstthe back of the handpiece head. The girdle also has a product tag, andthe sensor indication and information from the product tag are providedto a controller.

In accordance with another aspect of this invention, in a handpiecehaving a handle for enabling a user of the handpiece to hold thehandpiece, and a head connected to the handle, the head including aturbine for rotating a burr and at least one bearing ring for supportingthe turbine, there are provided an element for detecting an operatingcondition of the at least one bearing ring, and at least one sensor forsensing whether the detected operating condition exceeds a threshold,and for providing an indication when the threshold is exceeded.

It is not intended that the invention be summarized here in itsentirety. Rather, further features, aspects and advantages of theinvention are set forth in or are apparent from the followingdescription and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram showing product management system 10;

FIGS. 2A-2F are block diagrams showing embodiments of field device 70;

FIG. 3 is a flowchart showing pre-shipment processing;

FIG. 4 is a flowchart showing post-shipment processing;

FIGS. 5A-5B are views of a conventional dental handpiece;

FIGS. 6A-6B are views of one embodiment of a clip-on girdle for ahandpiece;

FIGS. 7A-7B are views of another embodiment of a clip-on girdle for ahandpiece;

FIGS. 8A-8B are views of a handpiece according to the present invention;

FIGS. 9A-9B are views of a conventional sterilization pouch;

FIG. 10 is a view of an embodiment of a sterilization pouch; and

FIG. 11 is a view of an embodiment of an injector.

DETAILED DESCRIPTION

Referring now to the drawings, and in particular to FIG. 1, there areillustrated communication network 5, product management system 10,customer 20, customer practice management system 25, shipping module 60,field device 70 and regulator 95.

Communication network 5 may be any wireline or wireless network, such asthe Internet, a private virtual network, a private dedicated network andso on. Further, communication network 5 may be embodied as a pluralityof networks, for example, a wireline data network and a wireless voicenetwork.

Product management system 10 includes communications interface 15,product information tag (PIT) preparation module 30, PIT preparationrules 35, PIT database 50, database viewer 55, report preparation module80, report preparation rules 85, and analyst 90.

Product management system 10 is embodied as a general-purpose computerprogrammed in accordance with the present description. Thegeneral-purpose computer can be one computer or many computers networkedtogether. System 10 can operate on dedicated or shared hardware, and maybe at a user's premises or available as a so-called “web service”through communication network 5 or other communication facility. Whensystem 10 is available as a web service, analyst 90 communicationstherewith via communication network 5, in similar manner as regulator95.

Customer 20 is able to communicate with product management system 10 viacommunication network 5. In some embodiments, customer 20 has a generalpurpose computing device, such as a personal computer. In otherembodiments, customer 20 has practice management system 25 which may beany conventional system for storing patient records, modified to alsostore PIT and other information described below, for example, theDENTRIX® system available from Henry Schein, Inc. A typical practicemanagement system has a front-office portion for handling appointmentscheduling and payments, a mid-office portion for handling patientrecords and a back-office portion for handling diagnostic and treatmentinformation, as well as a patient portal enabling a patient to accesstheir appointments and medical information via a communication networksuch as the Internet. In the examples described below, it iscontemplated that information associated with products by a productsdistributor is captured by practice management system 25 and associatedwith the appropriate patient record.

In some embodiments, practice management system 25 uses communicationnetwork 5 to provide information to product management system 10, suchas product usage and location information, and/or to receive informationfrom product management system 10, such as recommended operatinginstructions and product supply chain information.

PIT preparation module 30 is adapted to generate PITs for products inaccordance with customer order 20 and PIT preparation rules 35. Productstypically are medical or pharmaceutical supplies, such as drugs ordevices.

As used herein and in the claims, “PIT” means a record relating to aproduct that logically accompanies the product, and that may or may notphysically accompany the product in whole or in part. In contrast, a“label”, as the term is customarily used in the medical productsindustry, must physically accompany the product and include requiredstandardized information.

A PIT may be embodied in any of the following ways: (a) as a printedpaper affixed to a product or a product's container, (b) as a printedpaper accompanying a product, (c) as an electromagnetic device affixedto or accompanying a product that stores information, (d) as anelectromagnetic device affixed to or accompanying a product that enablesaccess to information stored about the product, the information beingstored in other than the electronic device that serves as the PIT, (e)combinations of the above, or (f) other configurations apparent to oneof ordinary skill. Thus, a PIT may be information associated with apaper, such as a bar code, and/or information associated with anelectronic or magnetic device.

Electronic devices suitable for a PIT include a radio frequencyidentification (RFID) tag, a “smart card” typically comprising acredit-card sized device with a processor and memory, a pattern that ismagnetically readable as a bar code, and other devices that will beapparent to those of ordinary skill in the art.

Generally, the PIT serves to uniquely identify the product relative toother products in PIT database 50.

Customer 20 provides an order that typically includes identification ofthe desired product, quantity, a ship-to address, an order date andsometimes a delivery date and/or other special instructions. Theinstructions may be provided directly or indirectly. An example ofindirect instructions is when a customer is in a country whoseregulations stipulate certain requirements; the customer is deemed tohave indirectly provided the certain requirements. The customer ordermay specify features of the product, for example, the type of container,and optional features such as stickers for patient charts, the stickersbearing product-related information.

PIT preparation rules 35 include product handling information based onthe type of product, e.g., refrigerated, customer predefinedpreferences, shipping company requirements, regulatory requirements inthe country of origin, regulatory requirements in the destinationcountry, destination country characteristics such as officiallanguage(s), customs requirements, and special instructions in orrelated to the customer order.

The information in PIT preparation rules 35 relates to:

-   -   package layout and appearance;    -   what type of PIT should be used, i.e., sticker on product,        product insert, electronic tag, bar code;    -   what historical information about the product content must be on        its PIT: lot code, manufacturer date, serial number, UPC code        and so on;    -   PIT information for the product container: whether refrigerated        shipping is needed, individual container, package container,        carton container, shipping pallet and so on;    -   associated products, e.g., syringes for fluids;    -   product trademark requirements;    -   promotional materials;    -   advice to include restrictions to be applied (ex: how to use,        how to distribute, how to store);    -   whether a sensor is to be applied, and what type sensor may be        appropriate; and    -   information related to communicating post-shipment information,        such as if a product complaint has to be forwarded within a        predetermined number of days after the complaint is received, if        the complaint should generate a warning message or a reminder to        appropriate parties such as the manufacturer.

For example, let it be assumed that the customer order specifies that100 units of high speed dental operatory handpieces are to be sent to alocation in Moldova and are to have RFID tags with serial numbers. PITpreparation rules 35 specify that Moldova requires medical deviceinstructions to be in Russian and in French, that the manufacturer ofsuch handpiece as identified under Moldovian regulations bedeterminable, although not necessarily from the product PIT; that thecustomer wants its instruction sheets to have its name on the sheets,and the instructions in German and English, and its name affixed to theproduct itself; and that the regulatory requirements for Korea, thecountry of manufacture, specify that the date of manufacture must be onthe PIT for the device.

In this example, PIT preparation module 30 creates PITs having stickersto be affixed to the handpieces having the customer name and the date ofmanufacture, creates inserts on paper having instructions for use inRussian, French, German and English, and creates RFID tags to be affixedto the handpieces containing the serial number of the respectivehandpieces.

When PIT preparation module 30 generates PIT 40, it also generates a PITrecord and places the PIT record in PIT database 50. The PIT recordincludes at least the information provided in the PIT, and typicallyincludes additional information. The PIT record serves as an audit trailfor the past, present and future information about the product.Generally, the past information refers to the manufacturing history ofthe product, including manufacturer, product type, product serial numberand UPC code, product version number, manufacture date, expiration date(if any), previous owners of the product, whether the product has beensubject to recalls and field corrective actions, the number of previoussterilization procedures, extremes in storage conditions, and so on. Thepresent information refers to instructions for use, which can be in oneor more languages, or contain one or more pointers to instructionallanguage, the present location of the product, and so on. The futureinformation refers to the customer, the product's actual use, theshipper, the shipment route (if appropriate) and so on.

Supply chain information refers to information relating to how a productarrived at its current location, particularly, who had possession of theproduct, when, and the conditions experienced by the product while in aparty's possession, such as ambient temperature and humidity ranges. Alocation sensing system, such as the global positioning system (GPS),can be a source of supply chain information.

In some embodiments, the PIT record includes information provided to thecustomer, as well as information provided from the customer, or theproduct itself while in the customer's possession.

During the lifetime of the product, the definition of present and futureadapts. That is, after the product is received by the customer, theshipper becomes part of the past information. Usage and exceptionreports are then provided by the customer and/or the product, asdiscussed below.

Database viewer 55 enables a person, such as analyst 90, to view thecontents of PIT database 50. Database viewer 55 is embodied as softwarefor interacting with PIT database 50. Analyst 90 represents and suitablehardware for enabling a person to view information, such as a terminalor personal computer and/or printer. Database viewer 55 typicallyenables analyst 90 to formulate queries and apply them to PIT database50. Many commercial database packages are known and suitable, such asMicrosoft Access, MySQL, Oracle and so on.

PIT database 50 may be used for the following purposes:

-   -   to provide information to manufacturers for sales programs and        recalls,    -   to provide information for product liability lawsuits        quantifying the amount of product from a particular products        distributor involved in malfunctions and the like,    -   for data mining,    -   to project product failure rates and the need to replace the        product and/or maintain an inventory of spare replacement parts,    -   to indicate which customers to focus on based on the customer's        activity with regard to various procedures,    -   to recommend complementary or substitute products,    -   to provide different levels of customer support depending on the        value of the customer,    -   to help decide where to locate sales and/or service centers,        typically near the most frequent users of products.

Shipping module 60 enables the shipping service to update the PITrecord, to indicate the present location of the product. Packagetracking services are well known, and employed by, for example, UPS,Federal Express and the United States Post Office. In some embodiments,shipping module 60 is part of system 10, and queries the shipper'spackage tracking service for the status of products in transit. Shippingmodule enables a person or system associated with a shipping service toupdate the PIT record. Additionally, if a shipper has field device 70,PIT 40 may update the PIT record.

Field device 70 enables a customer or other authorized party to access aPIT record, and to update a PIT record with usage and exceptioninformation. Each PIT record may contain not only actual product usageinformation, but also supply chain information for the product. In someembodiments, field device 70 also transmits PIT and possibly otherinformation directly to practice management system 25, so that the PITand other information can be associated with patient records, enabling apatient record to directly provide product supply chain information.FIGS. 2A-2F show embodiments of field device 70.

Field device 70 can be located at any point along the product supplychain, including shipper premises, doctor premises and patient premises.

Usage information refers to customary activity that the product isinvolved in. For example, if the product is a device or medicine, thefact that it was subjected to temperatures above a first threshold orbelow a second threshold at any time is a usage event. If the product isa medicine, the fact that it was used (ingested, applied, etc.) by apatient on a certain date and time is a usage event. Lack of usage isalso a form of usage information. Another example of a usage event isbeing dropped.

Exception information relates to an abnormal event associated with theproduct. For example, if the product is a device, a device failure is anexception event. If the product is a medicine, a side-effect in thepatient, such as an allergic reaction, is an exception event.

In a simple case, the customer submits a usage and/or exception eventvia a written or faxed letter, possibly using a form.

FIG. 2A shows field device 70 as comprising customer personal computer(PC) 110 and printer 115. Here, the customer communicates with PITdatabase 50 via electronic mail, or via a website. In some cases, theproduct PIT may need to be updated, and the updating occurs usingprinter 115. It will be appreciated that PC 110 may be a desktop,laptop, tablet or handheld personal computer, or a personal digitalassistant, or even a cellular telephone with suitable processingability.

Field device 70 is shown coupled to communication network 5. It will beunderstood that this coupling represents a path to a central computer,such as product management system 10, and/or, in some embodiments, to alocal computer such as practice management system 25.

FIG. 2B shows field device 70 as comprising customer PC 120 andreader/writer 125. Here, the product bears or is associated withelectronic PIT 42, such as an RFID tag or smart card. Reader/writer 125reads information from electronic PIT 42, and passes the readinformation to PC 120, which in turn uses the read information to accessthe desired PIT record from PIT database 50. When PC 120 updates the PITrecord, PIT database 50, or a program running in PC 120, may updateelectronic PIT 42 accordingly.

FIG. 2C shows field device 70 as comprising PC 130 and reader/writer135. PC 130 and reader/writer 125 can communicate with each other, andeach can communicate directly with PIT database 50. Here, the productbears or is associated with electronic PIT 43 and sensor(s) 44. Sensor44 is adapted to detect regular usage events and some exception events,and to provide this information to electronic PIT 43. In someembodiments, sensor 44 also provides detected usage events and exceptionevents directly to PIT database 50, for example, via wirelesscommunication or via daily “synchronization” sessions or via as-neededsynchronization sessions. In a synchronization session, the productcommunicates with PIT database 50, generally to provide information toPIT database 50. PC 130 is able to query PIT database 50, and also toreport usage and/or exception events that are beyond the capability ofsensor 44.

For example, if the product is a dental handpiece for holding drillbits, also referred to as burrs, sensor 44 may detect temperatures overa high threshold, such as 220° F., indicating that the handpiece hasbeen subjected to a sterilization procedure; and also may detecttemperatures under a low threshold, such as 40° F., indicating that thehandpiece has been subjected to a lubrication procedure. That is,handpiece lubrication is often performed using a spray having apropellant that creates low temperatures.

As another example, high value implants such as heart pacemakers,titanium posts screwed into bones, dental implants, artificial knees andthe like may have an embedded sensor that can be wirelessly read, incombination with a product information tag, to provide device status.

FIG. 2D shows field device 70 as comprising cellphone 140. Here, thecustomer uses cellphone 140 to call system 10 and verbally inquire aboutthe PIT record and/or verbally provide a usage and/or exception event.Security measures may be employed, such as ensuring that the callingcustomer is actually the customer to whom the product was shipped.

FIG. 2E shows field device 70 comprising cellphone 141 and sensor 142that automatically places a call to provide sensed information. In otherembodiments (not shown) field device 70 comprises a multi-media device,able to send and receive video and audio information, and also data, andpossibly able to print data. When field device 70 is a multi-mediadevice, the PIT information may comprise multi-media. For example, theusage instructions may be a video with closed-caption text and audio,explaining how to use the medical product. This form of presentation isparticularly helpful for handicapped and/or illiterate people.

Field device 70 may be a programmable infusion pump for providing adrug. Typically, an infusion pump is programmed to provide a quantity ofdrug based on the bodyweight of the patient, sometimes with the abilityfor a patient to manually request more drug up to a predeterminedmaximum amount. The usage pattern of this device, combining itsprogramming and the patient's manual requests, can be captured as partof a clinicial trial, to correlate usage to outcome.

Similarly, for a dental restoration (filling), the usage of acombination of devices, e.g., a desensitizer and a composite resin, canbe correlated with the clinical record and the patient outcome, toidentify best usage techniques.

FIG. 2F shows field device 70 comprising internal communication network148, PIT 149, device 150, sensor 151, display 152, remote interface 153,local interface 154, processor with memory 155, and location assembly156. Internal communication network 148 may be a bus or a plurality ofpoint-to-point connections. Sensor 151 senses at least one operatingcondition of device 150. In one instance, device 150 is a dentalhandpiece, and sensor 151 is a bimetallic sensor that disengages thechuck mechanism of the handpiece when a predetermined temperature isreached, to prevent overheating, as shown in more detail in FIG. 8Abelow. Audiovisual display 152 displays an indication of the operatingcondition of device 150 to its user, such as a dentist. When sensor 151is triggered into sensing an event, either by usage of device 150 or bya poll received from remote interface 153 or local interface 154, sensor151 activates location assembly 156 to communicate with location network7, such as the global positioning system, to obtain the location ofdevice 150 as a location stamp. Processor with memory 155 storesreadings from sensor 151 in association with a time stamp and thelocation stamp, and provides the stored sensor readings and associatedtime stamp and location stamp to one or both of remote interface 153 andlocal interface 154, for transmission to product management system 10and practice management system 25, via remote communication network 5and local communication network 6, respectively.

The device of FIG. 11 is an embodiment of the configuration of FIG. 2F.

In some embodiments, a biometric reader, such as a fingerprint reader,voice recognizer, retinal scanner or the like, is used to determine whois using device 150, and/or the identity of the patient receivingservices via device 150. In other embodiments, a barcode scanner is usedto input the identity of the user and/or patient. The identityinformation is typically associated with the PIT information in practicemanagement system 25, but may be anonymized or absent from productmanagement system 10 due to privacy concerns.

In some embodiments, interfaces 153, 154 and processor with memory 155are in a cradle that device 150 having sensor 151 is placed into.

In combination with the PIT information, the sensor readings areanalyzed to assess the cause for unexpected failure of a device or classof devices. Analysis occurs as product management system 10, practicemanagement system 25, field device 70, or combinations thereof. A causeof failure may include usage patterns. Such assessment could be thebasis for notifying the operator of a potential problem, offeringmaintenance training to operators predicting future product failures,and avoiding product liability.

One of the concerns of dentists in using certain light cured materials,such as material used to fill a tooth cavity, is the degree of cureaccomplished during curing. To measure the amount of curing, a sensor issupplied with or built into the formulation of such light curedmaterial.

An example of a sensor supplied with the material is a membraneradiometer placed proximal to the material, between the material onand/or in the tooth and the light source that measures the amount oflight reaching the material, estimates therefrom the amount of curingand indicates when the estimated amount of curing (or amount of light)has reached a predetermined threshold. Another example of a sensorsupplied with the material is an external transducer for measuring thehardness of the cured material.

An example of a sensor built into the light cured material is a materialthat changes color when a certain temperature is reached. Anotherexample of a built-in sensor is a tiny transducer that measures pressurechange, indicating the hardness of the cured material.

In some cases, multiple sensors are simultaneously operative. Forexample, device 150 may be a pouch that an instrument is placed into,and then the pouch is placed in a sterilization device, such as anautoclave, an oven or other device, to raise the contents of the pouchto a sterilization temperature. Here, the pouch has a sensor, theinstrument has a sensor, and the sterilization device has a sensor. Oneexample of a pouch sensor is an ink that changes color based on itstemperature. Another example of a pouch sensor is a so-called indicatorink that changes color based on the amount of time it has been at orabove a temperature threshold and a predefined relative humidity. Otherexample of pouch sensors are electronic, mechanical, orelectromechanical device.

FIG. 3 is a flowchart showing pre-shipment processing.

At step 205, a customer order is received. At step 210, PIT preparationmodule 30 retrieves PIT preparation rules from PIT preparation rules 35.At step 215, module 30 creates PITs in accordance with the customerorder and PIT preparation rules. At step 220, module 30 creates a PITrecord in PIT database 50.

FIG. 4 is a flowchart showing post-shipment processing.

In one scenario, at step 305, a PIT record is accessed, via databaseviewer 55 or field device 70. The requested record is provided, andprocessing is complete.

In another scenario, at step 310, a usage event is written to a PITrecord. The usage event may be provided via field device 70, or manualinput (not shown) corresponding to the situations where the usage eventis provided via telephone, fax or paper mail.

In another scenario, at step 315, an exception event is written to a PITrecord. The exception event may be provided via field device 70, ormanual input (not shown) corresponding to the situations where theexception event is provided via telephone, fax or paper mail.

In another scenario, at step 320, a trigger is received, such as aperiodic trigger corresponding to time of day/week/month, or a one-timetrigger corresponding to receipt of an exception event. At step 325,report preparation module 80 retrieves report preparation rules fromreport preparation rules 85. At step 330, module 80 retrieves one ormore PIT records. At step 335, module 80 creates report(s) 90 inaccordance with the PIT records and report preparation rules 85.

Report(s) 90 comprise:

-   -   regulatory reports, such as reports of exception events,        particularly adverse patient reactions, that may be        electronically delivered to regulator 95,    -   customer activity reports that are directed to how much and/or        how often a product is being used, typically delivered to        analyst 90,    -   customer satisfaction reports that indicate problems and        customer comments both good and bad, typically delivered to        analyst 90, and    -   re-order reports that are automatically generated as a product        is used up or reaches the end of its lifetime and are        electronically delivered to customer 20.        Report(s) 90 are based on data collected from and/or in        association with PIT 40 while the product associated with PIT 40        is possessed by the product distribution, and other parties        having possession of the product subsequent to the product        distributor, including the shipper, the medical services        provider such as doctor or dentist, and perhaps the ultimate        patient.

To a distributor, an important piece of information is the customer'sdesire to reorder. Some distributors sell or supply scanners tocustomers, the scanners are for reading barcode labels identifying theproducts, so that reordering is accomplished via scanning. Typically,the barcode is unique to each manufacturer and carries themanufacturer's part number. Some distributors also affix their own barcode labels to a product, so that the product has two bar code labels,one from the manufacturer and the other from the distributor. In somecases, the customer, such as a large hospital chain or a dental school,may also affix its own bar code label to the product, so that theproduct has three bar code labels. Since the various bar code labels usedifferent formats, depending on the source of the label, it is helpfulto have an automated translation table between the various bar codes, toensure, inter alia, that a product is properly recognized.

With suitable access authorization, analyst 90 can update PITpreparation rules 35 and report preparation rules 85.

A handpiece is a unit, typically used in the medical and dentalprofessions, having a rapidly rotating member for altering the target,such as a patient's tooth, that is held in the hand of the partyproviding services to the target.

FIGS. 5A-5B show conventional dental handpiece 400 having head 410, stem425, handle 430, base 435 and cord 440. Head 410 is generally in theshape of a cylinder having face 415 and push button 405 opposite face415. Burr 420 is a removable drill bit inserted into the center of face415. In operation, a dentist presses push button 415, causing power tobe supplied via cord 440 to a turbine motor (not shown) inside head 410that causes burr 420 to rotate at high speed. The turbine motor issupported by two doughnut shaped rings of bearings inside head 410. Thebearing rings are respectively located towards the back and towards thefront of head 410, surrounding the turbine.

One of the causes of failure of a handpiece is normal wear and tear.Another that one of the causes of failure of a handpiece is poormaintenance. In some cases, poor maintenance manifests itself by achange in the operating characteristics of the product. An example ofthis would be the build up of heat in handpieces which have not beenproperly cleaned and lubricated internally. With the movement of dentalpractitioners toward an electric rather than an air-powered handpiece,this maintenance becomes even more important. With an air-poweredhandpiece, an improperly maintained handpiece will simply stop working.With an electric-powered handpiece, the electric drive motor willcontinue to move the gears even though there is a build up of foreignmaterial within the handpiece. The foreign material will cause frictionand result in heat build up. It has been reported that this has causedtemperatures to rise to the extent that patients have been injured. Therepair cost of an electric-powered handpiece can be 5-20 times the costof an air-powered handpiece.

Thus, measuring the heat of the turbine, and/or its vibration, is usefulfor detecting whether a handpiece is performing properly.

FIGS. 6A-6B are views of girdle 450 intended to clip on to handpiece400, specifically, to wrap around handpiece head 410. Girdle 450 hasspine 451, back support 454 having flexible membrane 452, back detectionband 456 and front detection band 458. Detection band 456 has vibrationsensor 462 at one end, and temperature sensor 464 at its other end.Detection band 458 has vibration sensor 466 at one end, and temperaturesensor 468 at its other end. Sensors 462, 464, 466, 468 are generally inrespective planes orthogonal to the planes of the ends of detectionbands 458, 456; in some embodiments, the sensors are in the same planeas the detection bands. Spine 451 has product information tag 460 andsterilization sensor 469.

Girdle 450 may be formed of any suitable substance or combination ofsubstances, such as a lightweight flexible metal for detection bands456, 458, bimetallic material for sensors 464, 468 and piezoelectricmaterial for vibration sensors 462, 466. Sterilization sensor 469 may beink that changes color in response to temperature. Temperature sensors464, 468 can change shape in response to temperature, as is typical fora bimetallic material, and/or can change color. Vibration sensors 462,466 can change color in response to vibration.

Operation of girdle 450 will now be discussed.

Handpiece 400 is typically sterilized after each use. Similarly, girdle450 is sterilized after each use, such as by putting girdle 450 in anautoclave or oven and raising the ambient temperature so that thetemperature on the surface of girdle 450 reaches a predeterminedtemperature. Sterilization sensor 469, which may be printed ink thatchanges color when the predetermined temperature has been reached,serves to verify that sterilization of girdle 450 has occurred.Sterilization sensor 469 may be reset by applying pressure thereto.

After sterilization, girdle 450 is placed on head 410 so that flexiblemembrane 452 covers push button 405, back detection band 456 isgenerally over the back bearings ring, and front detection band 458 isgenerally over the front bearings ring.

Flexible membrane 452 enables the dentist to activate the turbine bypressing push button 405. Flexible membrane 452 may advantageously blocksome force applied to push button 405, such as when a dentist improperlyrests push button 405 against a surface.

When handpiece 400 reaches a temperature above its normal operatingtemperature, the normal operating temperature being defined relative toeach type of handpiece, the back of head 410 typically is hottest, andthis temperature is picked up by back support 454 and communicated todetection bands 456, 458 via spine 451.

Detection band 456, being flexible, is responsive to the vibration andtemperature caused by the back bearings ring. When the vibration ofdetection band 456 exceeds a first vibration threshold, vibration sensor462 triggers, such as by changing shape or color. When the temperatureof detection band 456 exceeds a first temperature threshold, temperaturesensor 464 triggers, such as by changing shape or color. The triggeringof a sensor indicates to the dentist that maintenance is needed.

Detection band 458 operates in similar manner as detection band 456,except that band 458 is responsive to the front bearings ring.

In some embodiments, the sensor triggering is communicated to productinformation tag 460 and/or a processor or controller, such as in FIG.2C, via wireline or wireless communication. The processor can then cutoff power to the handpiece to ensure that the handpiece is not permittedto operate while it is too hot.

FIGS. 7A-7B are views of girdle 470, which is similar to girdle 450except that girdle 470 has stabilizer clip 472 at its rear, instead of aflexible membrane, and has only one sensor.

FIGS. 8A-8B are views of handpiece 490, which is generally similar tohandpiece 400. For brevity, only the differences will now be discussed.

Handpiece 490 has head 491 having built-in detection bands 492, 494,product information tag 493, temperature indicator 496, vibrationindicator 498, and sterilization indicator 499. Detection bands 492, 494may be on the outside of head 491, the inside of head 491, or located incut-out areas of head 491, as shown. Similar to detection bands 456,458, detection bands 492, 494 respectively serve to detect temperatureand vibration from the back and front bearing rings of handpiece 490.Respective temperature and vibration sensors, similar to those describedabove with respect to girdle 450, are located inside head 491, and causeindicators 496, 498 to light when appropriate thresholds are passed.Sterilization sensor 499 is similar to sterilization sensor 469 ofgirdle 450.

Handpiece 490 has base 436 having cords 441, 442 extending therefrom toa controller (not shown in FIGS. 8A-8B, but generally shown in FIG. 2C).Cord 441 provides power, similar to cord 440 of handpiece 400. Cord 442provides electrical signals from the temperature and vibration sensorsof head 491, and possibly signals to and from PIT 493, as generallyshown in FIG. 2C. The controller is able to terminate power to thehandpiece when the operating characteristics of the handpiece are deemedto be unacceptable.

In some embodiments, the sensors in handpiece 490 terminate power to theturbine when the appropriate thresholds are passed.

In some embodiments, the user of handpiece 490 is given theopportunity—but is not required—to indicate to the controller that usageinstructions were read prior to use. The controller stores theindication, if provided, which is useful for subsequent investigationsif a problem arises with the handpiece. In other embodiments, thecontroller requires that the user of handpiece 490 certify that usageinstructions were read before enabling power to handpiece 490.

FIGS. 9A-9B are views of conventional sterilization pouch 500 havingback 505, front 510 and adhesive strip 515. Typically, back 505 isformed of paper while front 510 is formed of transparent plastic. Front510 is permanently affixed to back 505 along three edges. The unaffixededge of front 510 is opposite adhesive strip 515. When the portion ofback 505 bearing adhesive strip 515 is folded over the unaffixed edge offront 510, the unaffixed edge becomes affixed and a pouch is formed.Imprinted on the side of back 505 facing the pouch is temperature sensor520, formed of thermally sensitive ink, which changes color when apredetermined temperature is reached. On the side of back 505 outsidethe pouch is sensor 525, formed of sensitive ink in a first color, whichchanges to a second color is the presence of chemical vapor or steam,and changes to a third color in the presence of ethylene oxide.

U.S. Pat. No. 5,344,017 shows another known sterilization pouch, inwhich the equivalent of sensor 520 is encased in a diamond shape formedby affixing the back to the front along lines forming a diamond.

FIG. 10 is a view of sterilization pouch 550. Sterilization pouch 550 isgenerally similar to pouch 500, and for brevity, only differences willbe discussed.

Sterilization pouch 550 includes sensors 571, 572, 573 formed ofthermally sensitive ink that changes color when different temperaturethresholds t₅₇₁, t₅₇₂, t₅₇₃ are reached. Together, sensors 571, 572, 573form an integrator. Sensors 571, 572, 572 are located behind panel 581,which ensures that the ink from the sensors does not contaminate thedevice being sterilized. In some embodiments, panel 581 is omitted.Panel 581 is typically transparent plastic.

Sterilization pouch 550 also includes sensors 574, 575, 576 that triggerwhen different temperature thresholds t₅₇₄, t₅₇₅, t₅₇₆ are reached.Sensors 574, 575, 578 are adapted to be read either electronically,magnetically or electromagnetically by an external sensor reader (seeFIG. 2C). Sensors 574, 575, 578 are located behind panel 582, whichensures that the sensors remain separate from the device beingsterilized.

Sterilization pouch 550 also includes PIT 590.

As used herein and in the claims, injector refers to a syringe or anauto-injector. A syringe is a device having a fluid and a hypodermic(hollow) needle wherein manual action of the user provides force forforcing the fluid through the hypodermic needle. An auto-injector is adevice having a fluid, a spring and a hypodermic needle wherein the usermerely places the uncapped device against his or her skin to release thespring that provides force for forcing the fluid through the hypodermicneedle. Auto-injectors are well known, for example, U.S. Pat. Nos.5,092,843 and 5,354,286, having a common inventor herewith, thedisclosure of which is hereby incorporated by reference.

In some situations, such as exposure to bee stings for persons allergicthereto, or exposure to chemical agents, receiving an injection iscritical for a person to stay alive. Chemical agents include nerveagents such as soman and sarin, biological agents, blood agents such ashydrogen cyanide, and other toxins. Persons at risk of such situationsoften carry an injector with them, since after realizing they have beenexposed to danger, they have only a few moments of consciousness and soit is critical that an injector be nearby. In general, in a high threatsituation with a rescue device, it is desirable for the rescue device,upon being used, to send a rescue signal indicating its location, sothat rescue personnel can more readily know that their services areneeded and find the harmed person. Additionally, for persons who shouldbe carrying a rescue device, it may be desirable to remind such personsif their rescue device is not being carried.

FIG. 11 is a side view of injector 600. Injector 600 is shown as asyringe but, in other embodiments, is an auto-injector. When injector600 is used to dispense its dosage, it determines its location, andsends a message to a central facility, such as a rescue center orproduct management system 10, giving its unique identification numberand its location. The central facility uses the unique identificationnumber to determine the contents of injector 600 and thus what sort ofthreat may have occurred so that suitable rescue personnel may bedispatched. The unique identification number may also be associated witha likely user of the device, and the user's organization may be notifiedthat a problem has occurred and help is on its way. Injector 600 is anembodiment of the configuration of FIG. 2F.

Injector 600 includes housing 605, stem 610, plunger 615, movable disc620, end cap 630, dosage chamber 640, hypodermic needle 645, needle cap650, sensor 660, processor with memory 665, communications interface670, PIT 675, battery 680 and location interface 685. Dosage chamber 640is at least partially filled with rescue fluid.

When a user feels the need for rescue fluid, the user removes end cap630 and needle cap 650 from injector 600, inserts needle 645 into theuser's skin, then presses plunger 615 towards housing 605. The forceapplied to plunger 615 is transmitted to disc 620 via stem 610. Themovement of disc 620 towards needle 645 forces the rescue fluid throughneedle 645 and into the user.

Usage of an auto-injector is described in U.S. Pat. Nos. 5,092,843 and5,354,286.

Sensor 660 is inside housing 605, and is triggered by the movement ofdisc 620. In some embodiments, sensor 660 is triggered by the movementof stem 610. When sensor 660 triggers, it provides a signal to processor665 via magnetic coupling or a physical contact made through a hole inthe wall of housing 605. Processor 665 activates location interface 685to obtain the location of injector 600, such as global positioningsystem (GPS) coordinates. Processor 665 then activates communicationinterface 670, such as by initiating a cellphone call to a predeterminedtelephone number associated with a central facility, and whencommunications are established, provides a unique identification numberstored in PIT 675 along with the location from location interface 685and possibly a timestamp. In some embodiments, instead of using avoiceband cellular channel, communication interface 670 uses anemergency frequency or a control channel or another wireless channel.Battery 680 can be in a standby or non-use state until sensor 660 istriggered, and only needs to provide power for the aforementionedactivities, so battery 680 can be small.

In one case, disc 620 has a coating on its backside (side away fromdosage chamber 640) that couples with sensor 660 to provide a firstresistance to processor 665; when disc 620 is de-coupled from sensor 660during use of injector 600, sensor 660 alone provides a secondresistance to processor 665. The change in resistance, or the secondresistance, seen by processor 665 serves as the trigger signal.

When the central facility is product management system 10, communicationnetwork 5 is the public switched telephone network coupled to thecellular telephone network that receives the call from processor 665 viacommunications interface 670. Communications interface 15 of productmanagement system 10 serves to receive the call and store the event ofthe call in PIT database 50. PIT database 50 includes, in the recordrelating to the injector, the contents of the injector and an identityof a person having the injector. Rules database 85 includes a rule thatwhen a call from injector 600 is received, an alert report is to beimmediately prepared and delivered to analyst 90. In some embodiments,the rule or the database record relating to the injector specifies otherparties that the alert report is to be delivered to, such as customer20. Analyst 90 then arranges for dispatching of rescue personnel to thelocation of injector 600.

In some embodiments, injector 600 is configured so that the centralfacility is alerted when injector 600 is not being carried by the user,and can contact the user, such as by telephone or email, to remind theuser to carry injector 600. As used herein and in the claims, detectingusage of an injector encompasses detecting when fluid is being forcedthrough the injector's hypodermic needle, and detecting when the deviceis or is not being carried by the user.

In some cases, injector 600 periodically reports its location to thecentral facility, either by initiating a location transmission orresponding to a location poll from the central facility. The centralfacility then compares at least two successive location reports todetermine whether injector 600 is moving. Lack of motion indicates thatthe user might have forgotten to carry the injector.

In some cases, injector 600 periodically checks its location, stores itscurrent location, and compares at least one of its stored previouslocations with its current location, and notifies the central facilityonly if the comparison indicates no change, that is lack of motion.

With respect to movement detection, the location sensor can use GPScoordinates or can use a local metric, such as the position of a drop offluid in a chamber, or any other metric that changes based on movementof the injector.

Although illustrative embodiments of the present invention, and variousmodifications thereof, have been described in detail herein withreference to the accompanying drawings, it is to be understood that theinvention is not limited to these precise embodiments and the describedmodifications, and that various changes and further modifications may beeffected therein by one skilled in the art without departing from thescope or spirit of the invention as defined in the appended claims.

1. A removable girdle for a handpiece, the handpiece having a head witha turbine supported by at least one bearing ring, comprising: an elementfor detecting an operating condition of the at least one bearing ring,and at least one sensor for sensing whether the detected operatingcondition exceeds a threshold, and for providing an indication when thethreshold is exceeded.
 2. The removable girdle of claim 1, wherein theelement consists of a first band configured to correspond with a backbearing ring of the handpiece, and a second band configured tocorrespond with a front bearing ring of the handpiece.
 3. The removablegirdle of claim 1, wherein the operating condition is represented by thetemperature of the handpiece head.
 4. The removable girdle of claim 1,wherein the operating condition is represented by the vibration of thehandpiece head.
 5. The removable girdle of claim 1, wherein the sensoris bimetallic.
 6. The removable girdle of claim 1, wherein theindication is visual.
 7. The removable girdle of claim 1, having atleast one sensor for detecting the temperature of the handpiece head,and at least one sensor for detecting the vibration of the handpiecehead.
 8. The removable girdle of claim 1, further comprising a flexiblemembrane for covering the back of the handpiece head.
 9. The removablegirdle of claim 1, further comprising a stabilizer clip for supportingthe girdle against the back of the handpiece head.
 10. The removablegirdle of claim 1, further comprising a product tag.
 11. The removablegirdle of claim 10, wherein the sensor indication and information fromthe product tag are provided to a controller.
 12. In a handpiece havinga handle for enabling a user of the handpiece to hold the handpiece, anda head connected to the handle, the head including a turbine forrotating a burr and at least one bearing ring for supporting theturbine, the improvement comprising: an element for detecting anoperating condition of the at least one bearing ring, and at least onesensor for sensing whether the detected operating condition exceeds athreshold, and for providing an indication when the threshold isexceeded.
 13. The handpiece of claim 12, wherein the element consists ofa first band configured to correspond with a back bearing ring of thehandpiece, and a second band configured to correspond with a frontbearing ring of the handpiece.
 14. The handpiece of claim 12, whereinthe operating condition is represented by the temperature of thehandpiece head.
 15. The handpiece of claim 12, wherein the operatingcondition is represented by the vibration of the handpiece head.
 16. Thehandpiece of claim 12, having at least one sensor for detecting thetemperature of the handpiece head, and at least one sensor for detectingthe vibration of the handpiece head.
 17. The handpiece of claim 12,further comprising a product tag.
 18. The handpiece of claim 17, whereinthe sensor indication and information from the product tag are providedto a controller.
 19. The handpiece of claim 18, wherein the controllerreceives and stores an indication of whether usage instructions for thehandpiece have been read by a user of the handpiece.
 20. The handpieceof claim 12, wherein when the threshold is exceeded, power to theturbine is terminated.
 21. The handpiece of claim 12, further comprisingan indicator for indicating whether the handpiece has been sterilizedsubsequent to usage of the handpiece.